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Developing and Validating Blood and Imaging BIOmarkers of AXonal Injury Following Traumatic Brain Injury

Developing and Validating Blood and Imaging BIOmarkers of AXonal Injury Following Traumatic Brain Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534154
Acronym
BIO-AX-TBI
Enrollment
313
Registered
2018-05-23
Start date
2017-11-30
Completion date
2021-12-30
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief summary

Observational longitudinal study assessing outcomes following moderate-severe traumatic brain injury (TBI).

Detailed description

Traumatic brain injury (TBI) occurs when the brain is physically damaged, for example after a car crash. It is common and survivors often have major on-going problems. It is very difficult to predict how patients will do after TBI. One reason for this is that clinicians and researchers are unable to measure all the effects of TBI. An important factor is that the connections between nerve cells are damaged by the impact on the brain of an injury (axonal injury). This damage has been difficult to measure in the past, but new ways to scan the brain and more sensitive ways of picking up the effects of this injury in the blood could change this. In other parts of medicine tests of this type have had a dramatic effect on how clinicians treat patients. For example, the products of heart muscle damage that have leaked into the blood can be used identify a heart attack and guide treatment. Clinicians need similar tests to be available in TBI. This should be possible as the products of axonal injury also leak into the blood and researchers have a sensitive way to pick this up. An accurate test for axonal injury would guide treatment choices and allow clinicians to predict how patients will recover. The investigators have brought together an international team who have been working on different aspects of this problem for many years. Together the investigators will conduct a large study to identify the best measures of axonal injury. The investigators will carefully test whether these measures help predict outcomes and will study where the blood markers come from using a safe method to measure the effects of axonal injury directly from the brain. The work links into some large projects that have already started and will use a standard way to assess patients after their injury. This is important because it will allow researchers to share results across studies. The investigators hope the work will allow us to identify a blood marker for TBI that could be widely used to quickly identify the presence of axonal injury. The investigators will also show what brain imaging measure is best at picking up axonal injury and how best to combine the measures to best predict how patients recover. This will allow doctors to diagnose problems after TBI more accurately, choose the right treatments and give patients and their families accurate advice about what will happen after discharge from hospital.

Interventions

DIAGNOSTIC_TESTMRI

Magnetic Resonance Imaging

DIAGNOSTIC_TESTBlood Sampling

Sampling of serum

DIAGNOSTIC_TESTMicrodialysis

Monitoring of cerebral fluid protein levels

DIAGNOSTIC_TESTNeuropsychological tests

Battery of tests to assess cognitive function, patient outcomes

DIAGNOSTIC_TESTMRI (advanced)

Advanced MRI

Sponsors

Centre Hospitalier Universitaire Vaudois
CollaboratorOTHER
University College, London
CollaboratorOTHER
Istituto Di Ricerche Farmacologiche Mario Negri
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* A diagnosis of moderate/severe traumatic brain injury (TBI) as classified using the Mayo classification system; * Healthy controls will be age-matched to our TBI patients and will not have a history of significant neurological or psychiatric conditions.

Exclusion criteria

* Unwillingness or inability to follow the procedures required * Bilateral fixed dilated pupils * For MRI, contra-indication to MRI scanning, assessed by a standard pre-MRI questionnaire (e.g. presence of ferromagnetic implants in the body, claustrophobia, pregnancy) if considered for the imaging strand of the study.

Design outcomes

Primary

MeasureTime frameDescription
Change in diffusion tensor imaging measures over time10 days - 6 weeks, 6 months and 12 monthsFractional anisotropy (FA)
Brain atrophy rates10 days - 6 weeks, 6 months and 12 monthsBrain tissue volume changes over time.
Change in levels of fluid biomarkers in blood0-5 days, 5-10 days, 10 days - 6 weeks, 6 months and 12 monthsNeurofilament light and Tau protein
Change in levels of fluid biomarkers in cerebral fluid48 hours to 7 daysNeurofilament light and Tau protein

Countries

Italy, Slovenia, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026